CCTR News

CCTR Science Day Focuses on Ethical Issues in Research Involving Children and Adolescents

Another engaging Science Day took place May 16, 2017, as CCTR members gathered in a packed room at the UW Center for Urban Horticulture to share their research and discuss the interplay of bioethics and translational research. As always, Science Day co-chairs Drs. Eileen Klein and Cate Pihoker arranged an exciting lineup of presentations and poster sessions.

The keynote speaker, Dr. Steven Joffe, spoke about the tension inherent in the FDA drug approval process, and how to potentially speed up the process. In his talk, Access vs. Evaluation: An Enduring Dilemma in Therapeutic Development, he detailed the public hearings and controversy surrounding the eventual approval of eteplirsen for treating Duchenne muscular dystrophy, which serves as a litmus case for critical unmet medical need with strong patient advocacy. He provided an overview of the approval process in the U.S., debunking the myth that the FDA is slower than peer regulatory bodies, such as the corresponding agency in Europe. Joffe is the Emanuel and Robert Hart Associate Professor of Medical Ethics and Health Policy at the University of Pennsylvania Perelman School of Medicine and is an expert on ethical issues in the conduct of high-risk clinical and translational investigation.

Another highlight from the day was a panel discussion of a pediatric research ethics consultation. The primary question centered on re-contact of adults who were initially enrolled as infants in a research study by their parents. The study was of a sexually transmitted virus, genital herpes simplex virus (HSV), and the researchers wanted to know if they could re-contact the research participants – now young adults – to ask them to be in a research study, which would also disclose to them their mother’s status of having HSV. This case brings up questions about the importance of the research for anticipatory guidance about the long-term effects of neonatal HSV and the health of the now young adults and their sexual partners – and how to balance those concerns with their parents’ wishes not to disclose their HSV status to their children. Dr. Benjamin Wilfond, director of the Treuman Katz Center for Bioethics, summarized the case and moderated the panel discussion.

From left to right: Doug Diekema, Seema Shah and Steven Joffe.Joffe weighed in, saying, “Putting aside what was in the original consent form that parents signed, I would say it’s acceptable to contact the child (who is now an adult, let’s say a 20-year-old) directly because it impacts the child’s health and it’s currently in their medical record, so they can already figure out Mom had a sexually transmitted disease.”

Bioethicist and lawyer Seema Shah followed by asking the audience a provocative question: would paying the parents something to overcome their reluctance be acceptable? She queried the audience and found that most thought that paying $20 might be acceptable, but $2,000 made the audience uneasy. She noted that offers of payment cannot be coercive because they do not threaten to take anything away from people, and that we all make choices based on whether the incentives are worth the trade-offs to us. In this case, she suggested that “we should let people adjudicate among their own values.” She concluded that provided the research itself is important and does not pose substantial risks, researchers can make the monetary offer and let parents decide whether the trade-off fits with their own values and preferences. Nevertheless, researchers should minimize harm, so Shah argued that researchers should provide parents with information on how to have this sensitive discussion with their children to minimize emotional discomfort and avoid misunderstandings or miscommunications for both the parent and their adult child.

Dr. Doug Diekema said that he had no problem with an investigator approaching the adult children, but if doing so revealed private, identifiable information about that person’s parents, then this approach would not be acceptable. “One has to consider the parents’ privacy rights. It would be different if the re-contact and resulting disclosure didn’t implicate a parental health issue.” Wearing his hat as Institutional Review Board (IRB) chair, he commented, “As a general rule, competent consenting adults can be offered money or some combination of enticements to participate in research. IRBs worry, however, that some incentives might lead to overenrollment of a subset of the population who, due to their socioeconomic status, might be more willing to take chances with the risks of a research study – if enrollment seems limited to individuals with low incomes, then that is problematic.” He wrapped up his remarks by advising that researchers play close attention to what they put in the consent form. The wise thing is not to limit your future options and to keep the consent language as broad and as open as possible. He summed up the consult, “It’s why it’s an ethical dilemma – there is no perfect answer.” For more about this consult, see Research recruitment of adult survivors of neonatal infections: Is there a role for parental consent?

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